Duns Number:008171162
Device Description: Assure Lance Plus Safety Lancets 25g 100's. Single-use disposable blood lancet should be Assure Lance Plus Safety Lancets 25g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
Catalog Number
-
Brand Name
Assure® Lance Plus Safety Lancets
Version/Model Number
990125
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
d8afbca9-4383-4105-a9ae-2c11396bbb92
Public Version Date
October 25, 2018
Public Version Number
1
DI Record Publish Date
September 24, 2018
Package DI Number
10015482991255
Quantity per Package
24
Contains DI Package
00015482991258
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |